eSense™: The PHT family of medical devices integrated within the PHT ePRO System
Enabling researchers to collect and evaluate physiological patient measurements together with electronic patient-reported outcomes (ePROs).
eSense for Respiratory & Diabetes Trials
Wireless (Bluetooth®)1 Data Transfer Avoids Transcription Errors
Improving Science:
Integrated Peak Expiratory Flow (PEF) Meters and Glucometers enable scientific researchers to collect precise objective physiological data in conjunction with subjective patient-reported outcomes. The PHT eSense ePRO System delivers high-quality, attributable data that is 21 CFR Part 11 compliant.
Easy to Use:
Subjects use PHT eSense devices to measure their personal PEF or glucose levels. In addition to providing subjects with instant feedback on their current condition, device measurements are directly transferred via wireless sensor technology to each patient diary that stores each reading and compares it to previous measurements. Together with their personal diary data, eSense measurements are transmitted to the PHT StudyWorks™ web portal where clinical trial leaders and investigators can view cumulative real-time, time-stamped data.
Greater Efficiencies:
Integration of eSense medical dev ices with the PHT ePRO System provides greater value than the merely capturing PEF, Forced Expiratory Volume2 (FEV1), Forced Expiratory Flow3 rate (FEF) and Glucose measurements and ePRO data.
As smart devices, PHT diaries do more than simply collect and transmit eSense measurements. Each PHT ePRO device can be designed to
- Compare current with historical eSense data to trigger safety alerts;
- Execute calculations locally, without requiring transmission, for immediate safety messaging; and
- Trigger additional condition-specific questions formerly unavailable with separate and manual measurements.
PHT eSense for Respiratory Trials
PHT eSense respiratory monitors enable mobile monitoring and screening of subjects with chronic respiratory diseases, including asthma, cystic fibrosis, COPD and transplant patients. Each device measures airflow out of the lungs when blown into as hard and fast as possible, and can reveal narrowing of the airways well in advance of an asthma attack being felt by the asthmatic. Used mainly by subjects with moderate to severe and persistent asthma, PHT eSense respiratory measurements rapidly determine
- Which subjects qualify for a trial,
- How the treatment affects PEF readings,
- When subjects should contact their clinician; and
- Whether to modify the respiratory management and treatment plan.
The PHT eSense PEF meters are used by subjects over the age of five to monitor their respiratory treatment.
PHT eSense for Diabetes Trials
PHT eSense glucometers enable mobile testing, monitoring and screening of blood sugar for subjects within trials testing different drug mechanisms for the indication of diabetes. Blood sugar testing is essential for all people with diabetes, since the blood sugar level cannot be accurately determined by symptoms alone. Since diabetic subjects are committed to frequent blood sugar monitoring, compliance is generally high.
PHT eSense glucose measurements rapidly determine
- Which subjects qualify for a trial,
- How the treatment affects blood sugar levels,
- When subjects should contact their clinician; and
- Whether to modify the diabetic management and treatment plan.
The PHT eSense glucometers are used by subjects over the age of five. Measurements are use to adjust, insulin doses, medications, meal planning, and exercise to greatly improve blood sugar levels.
1. Bluetooth is a secure, short-range communications technology that allows wireless connectivity between devices such as mobile phones, personal computers and other devices.
2. FEV1 is the volume exhaled during the first second of a forced expiratory maneuver started from the level of total lung capacity.
3. Forced Expiratory Flow is the average flow (or speed) of air coming out of the lung during the middle portion of the expiration.
